Swissmedic, Swiss Agency for Therapeutic Products

PMDA International Forum, 8 February 2014 Swissmedic, Swiss Agency for Therapeutic Products Jürg H. Schnetzer, Executive Director

Grüezi. Bonjour. Buongiorno. Allegra. 2

Overview Swissmedic Introduction Strategic Approach to International Cooperation The International Pharmaceutical Regulators Forum Cooperation with MHLW/PMDA Current Challenges and Future Directions 3

Swissmedic Introduction Mission We are the central Swiss authority for the authorisation and supervision of therapeutic products We endeavour to ensure that authorised therapeutic products are of high quality, effective and safe We thereby contribute towards protecting the health of humans and animals We fulfil our legal mandate and work with partner authorities on a national and international basis 4

Swissmedic Introduction Swissmedic was established in January 2002 as the first Federal authority on therapeutic products along with the coming into force of the Therapeutic Products Act (TPA) Scope of products: Medicinal products for human and veterinary use (Chemical, biotechnology, biologic, stable blood products, transplant products, traditional and herbal medicines, ) Medical devices (based on EU system, Notified Bodies and CEmarking) 5

Swissmedic Introduction Core responsibilities Granting marketing authorizations for medicinal products Inspections & granting of authorisations to manufacturing facilities and distributors Market surveillance of medicinal products and medical devices Controlling the traffic of narcotics Laboratory testing and medicine quality Provision of information on therapeutic products Drafting laws, norms and standards 6

Swissmedic Introduction Key figures Staff: 360 FTE (440 employees) Budget 2014: ~ 90 Mio. CHF Federal contribution: < 20% Fees: > 80% 7

Swissmedic Introduction Organisation Agency Council President Christine Beerli Director Jürg H. Schnetzer Communication and Networking Petra Dörr HR & Finance Barbara Schütz Infrastructure Adrian Tschannen Marketing Authorisation Esa Heinonen Market Surveillance Karoline Mathys Licensing Hans-Beat Jenny Legal Affairs Andreas Balsiger 8

Swissmedic Introduction Change Process 2006-2012 Swissmedic QMS Reorganisation (process-oriented) Analysis of processes and organisation (Revision of Ordinance on fees) Development of strategy 2011-2014 Risk-based evaluation of resource allocation Analysis marketing authorisation 2012 2011 2010 2009 2008 2007 2006 9

Swissmedic Introduction Risk-based evaluation of resource allocation Risk-based evaluation of resource allocation Elements Analysis of current situation; developments/trends Show potential for process-optimisation International benchmark Involvement of external stakeholders 10

Swissmedic Introduction Risk-based evaluation of resource allocation Risk-based evaluation of resource allocation Common theme: Workload increases, resources stable 11

Swissmedic Introduction Risk-based evaluation of resource allocation Risk-based evaluation of resource allocation Additional resources approved based on analysis results: Headcount increase by 76 FTE (from 284 to 360 FTE) over three years 16 5 32 Marketing authorisation Market surveillance 8 15 Licensing Support (mainly IT) 12

Strategic Approach to International Cooperation Swissmedic in the national context Mature system for the regulation of therapeutic products Swissmedic: a small and medium sized agency Major location for research-based pharmaceutical and medical device industry Exports in pharmaceuticals: 64 Bio. CHF (2012, 30% of all Swiss exports) 14

Strategic Approach to International Cooperation National context Prioritisation Reliance Focussing on risk Conduct own assessment of innovative medicinal product applications Focus on maintaining high GXP standards in own territory Equivalence & trust Consideration of other regulators assessments for generic applications Rely on outcome of other regulators inspections for foreign manufacturing sites 15

Strategic Approach to International Cooperation Memoranda of Understanding/Confidentiality Agreements HPFB FDA IMB BfArM, PEI MFDS MHLW/ PMDA HSA ANVISA TGA Medsafe 16

Strategic Approach to International Cooperation Mutual Recognition Agreements Canada EU/EEA Australia 17

Strategic Approach to International Cooperation Multilateral Activities International Regulators Consortium (Australia, Canada, Singapore, Switzerland) World Health Organization: Pre-Qualification, trainings, Blood Regulators Network, Paediatric medicines Regulators Network, expert committees, PFIPC (Permanent Forum on International Pharmaceutical Crime) Council of Europe/European Pharmacopoeia 18

Strategic Approach to International Cooperation Multilateral Activities International Conference on Harmonisation (ICH) International Pharmaceutical Regulators Forum (IPRF) International Generic Drug Regulators Pilot (IGDRP) Pharmaceutical Inspection Cooperation Scheme (PIC/S) 19

International Pharmaceutical Regulators Forum History Established as the Regulators Forum in June 2008 in the margins of the ICH conference in Portland, USA, to provide a regulators-only platform for discussion around ICH topics (and beyond). Re-launch as the IPRF in June 2013 First meeting as the IPRF in November 2013 in Osaka, Japan 1.5 day meeting in conjunction with ICH conferences Chair: Swissmedic Co-chair: MHLW/PMDA Secretariat: Swissmedic 21

International Pharmaceutical Regulators Forum Objectives Practical and operational information-sharing on high priority regulatory issues; Support implementation of ICH and other internationally harmonized technical guidelines for medicinal products for human use; Regulatory cooperation, including work sharing, on identified topics which are not duplicative of existing processes or organizations; Open discussion and the sharing of best practices among the members; To identify existing synergies and commonalities with a view to develop common approaches. 22

International Pharmaceutical Regulators Forum Objectives In the context of a particular issue, identification of common need for development of better regulatory strategies, better information on specific issues or better training, e.g., for regulatory staff, to address specific issues; Identification of need for harmonization or convergence in specific areas (to improve regulatory operations efficiency and effectiveness); Propose identified topics, not falling in the remit of the IPRF, to appropriate existing process or venues (e.g. to ICH, PIC/S, APEC, PANDRH, WHO, etc.). 23

International Pharmaceutical Regulators Forum IPRF Activities Working group on General Principles for Training/Education of GCP inspectors Cell therapy working group Gene therapy working group Biosimilars working group 24

Cooperation with MHLW/PMDA MHLW and PMDA are strategic partners of Swissmedic Agreements of GMP and GLP in place since 1988 Confidentiality Arrangements signed in 2010 Annual bilateral meetings in the margins of the Summit of Heads of Medicines Agencies 26

Cooperation with MHLW/PMDA Focus areas for MHLW/PMDA and Swissmedic cooperation Staff exchange program (2013) March 2013: visit of PMDA staff member at Swissmedic to identify areas of interest for future cooperation October to December 2013: placement of a first PMDA liaison officer at Swissmedic November 2013: visit of Swissmedic staff member at PMDA 27

Cooperation with MHLW/PMDA Focus areas for MHLW/PMDA and Swissmedic cooperation Staff exchange program (2014) February 2014-February 2015: placement of PMDA liaison officer at Swissmedic 2014: Swissmedic staff member to visit PMDA (focus on drug safety and medical devices) 28

Current Challenges and Future Directions Current Challenges Keeping timelines while maintaining quality of scientific work Increasing complexity of the tasks (science, globalized supply chains) needs to handled without additional resources Increased efficiency and optimized processes required Modernization of infrastructure (IT) Recruiting and retaining qualified staff Need to consequently apply risk-based approach 30

Current Challenges and Future Directions Future Directions Effective resource management : (Pro-) active approach to resource allocation Horizon scanning : Issue management and regulatory intelligence for monitoring of new developments and trends Definition of future international positioning Dealing with increasing expectations with regard to transparency Continuing pressure on performance (keeping timelines) Maintaining attractiveness as an employer Elements of strategy 2015-2018 (work-in-progress) 31

Danke. Merci. Grazie. Grazia. 32